Regulatory submissions in life-science industries are the most critical milestones in a new product development process and in the further product lifecycle. A solid submission process can accelerate time to market, bring the benefit of new treatments to patients sooner, maximize research investments, and conserve patent life. RA staff have to deal with a variety of regulatory authority submission demands:
- Regulatory Authority meeting briefing packages
- NDAs/BLAs/MAAs, including 505(b)(1), 505(b)(2), 351(a), and 351(k) applications
- Orphan designation applications
- Fast-track designation applications
- Annual reports/DSURs/PSURs
The RA team has to cover a broad span of competences with expertise in pre-clinical, clinical, CMC, labeling, production processes, change control, project management, etc. How it’s done with Binocs? Have a look at our Regulatory Affairs Landing page.
Binocs and regulatory affairs: a perfect marriage for resource planning
Binocs is at its best when it has to plan highly skilled resources in a wide range of projects. Team leaders in RA are on a tight schedule and need to see the capacity roadblocks ahead in the coming months. Will we lack CMC experts, clinical writers, regulatory project leaders, etc.? How should we flex between teams? Where should we put planning priority? Regulatory affairs managers need to ensure that the sequence of activities for a submission is correctly executed. That’s where Binocs helps teams to collaborate. Binocs visualizes not only the dependencies within a submission, but also the impact of a potential capacity issue on all submission activities. Binocs is a Web application, and brings workforce-planning excellence across geographical borders. Binocs identifies the true root cause of a future capacity problem, and allows for action before a submission team is put in firefighting mode.
Binocs links with your submission system.
Binocs covers all important sources of demand for a submission team. Team leaders must be able to evaluate the full capacity picture, and not just a part of it. For each type of submission we’ll set up a method for capturing the demand that balances the data-entry effort with the business value of the output workforce-capacity plan. For example, Q&A submission effort is hard to plan. In this case we advise making a workload forecast based on historical data combined with projected events. Other submission events might be perfectly plannable because they are well identified on the roadmap for the next 12 months. Such events are mostly already registered in a submission system such as Liquent from Parexel. Binocs can periodically read the events from the submission system and translate them into workload for the different teams.
Be lean in regulatory affairs: Standardize your work and win twice.
You could estimate the expected workload for a submission each time afresh, and that would work fine for a Binocs resource plan. But in practice our advice would be to define standard work items for the different submission activities (as in Lean Six Sigma). Although, e.g., writers would claim that documenting a process change is never the same (and they are right), this doesn’t mean that we cannot categorize that activity into typical work items, like CMC writing for a minor or a major variation. By standardizing your work, you win once because your organization will execute activities more efficiently. And then you win a second time because your capacity plan will exactly pinpoint the standard work items for which you will lack workforce capacity, and that will prevent you from meeting the submission-due dates. Your action plan will be accurate and effective, and you will drastically increase the chances of delivering on time.
Have a look at our Regulatory Affairs Landing page. Discover the features for regulatory affairs and regulator operations in Binocs.